Abstract
BackgroundEarly suppression of disease activity in (rheumatoid) arthritis (RA) patients may result in drug-free remission and prevent damage. We assessed 2-year clinical and radiological outcomes of two disease activity score (DAS)-remission-steered treatment strategies in early arthritis patients.MethodsPatients (n = 610) with early RA or undifferentiated arthritis (UA) were treated with methotrexate (MTX) and tapered high dose of prednisone. Patients in early remission (44/53 joints DAS <1.6) after 4 months tapered and stopped medication. Patients who did not achieve early DAS-remission were randomized to either MTX plus hydroxychloroquine plus sulphasalazine plus low dose prednisone (arm 1) or to MTX + adalimumab (arm 2). At four-monthly intervals, medication was tapered and stopped if DAS was <1.6 but restarted, increased or switched if DAS was ≥1.6. Proportions of (drug-free) DAS-remission (DFR) after 2 years and Sharp-van der Heijde scores (SHS) were analyzed separately for the treatment strategies and patients with RA and UA.ResultsAfter 2 years, 301/610 (49 %) patients were in DAS-remission and 131/610 (21 %) in DFR. In the early remission group 241/387 patients (62 %) were in DAS-remission and 111/387 (29 %) DFR. In arm 1 22/83 (27 %) and in arm 2 24/78 (31 %) were in DAS-remission, and 6/83 (7 %) and 7/78 (9 %), respectively, were in DFR. RA and UA patients achieved DAS-remission in comparable percentages (RA: 234/479 (49 %), UA: 64/122 (52 %), p = 0.25). More UA patients achieved DFR (41/122 (34 %)) compared to RA patients (89/479 (19 %), p<0.001). Mean (SD) DAS over time was 1.74 (0.58) across all patients, and median (IQR) SHS progression was 0 (0–0).ConclusionsAfter 2 years remission-steered treatment in early RA and UA patients, DAS-remission and DFR percentages were relatively low. Patients who achieved early remission more often achieved (drug-free) remission after 2 years than patients who needed additional treatment steps in the randomization arms, and more UA than RA patients achieved DFR. Overall, disease activity and radiologic damage progression in all patients were well suppressed.Trial registrationhttp://www.controlled-trials.com/ISRCTN11916566 Registered 07/11/2006 and EudraCT number 2006-06186-16 Registered 16/07/2007.Electronic supplementary materialThe online version of this article (doi:10.1186/s13075-015-0912-y) contains supplementary material, which is available to authorized users.
Highlights
Suppression of disease activity in arthritis (RA) patients may result in drug-free remission and prevent damage
Several trials [5, 16,17,18,19,20] have shown that initial treatment with a combination including methotrexate (MTX) and corticosteroids results in earlier suppression of inflammation and damage progression
Secondary outcomes were drug-free remission (DFR) based on the proposed remission definition published by the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) in 2011 (Boolean) [26] mean disease activity score (DAS), mean functional ability as measured by the Dutch version of the health assessment questionnaire (HAQ) [27], radiological evidence of damage progression in the joints of the hands and feet (defined as an increase ≥0.5 points in the Sharp-van der Heijde score (SHS)) [28] and toxicity
Summary
Study design The IMPROVED study (ISRCTN11916566 and EudraCT number 2006-06186-16) is a multicentre two-step randomized single-blinded clinical trial designed by Dutch rheumatologists participating in the Foundation for Applied Rheumatology Research (FARR). Based on the costs of medication, and in view of a subsequent report on dose-dependent risk of side effects, ADA 40 mg/week is not approved in current daily practice [25] In both arms, if patients did not achieve remission on a combination of MTX + ADA 40 mg/week, further treatment decisions were left to the opinion of the rheumatologist (Fig. 1). Secondary outcomes were DFR based on the proposed remission definition published by the ACR/EULAR in 2011 (Boolean) [26] mean DAS, mean functional ability as measured by the Dutch version of the health assessment questionnaire (HAQ) [27], radiological evidence of damage progression in the joints of the hands and feet (defined as an increase ≥0.5 points in the Sharp-van der Heijde score (SHS)) [28] and toxicity. All statistical analyses were conducted with SPSS for Windows version 20.0
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